Drug-Induced Liver Injury in Clinical Trials: As Rare as Hens' Teeth
Drug-Induced Liver Injury in Clinical Trials: As Rare as Hens' Teeth
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DOI：
10.1038/ajg.2009.76
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发表时间：
2009-05-01
影响因子：
9.8
通讯作者：
Chalasani, Naga
中科院分区：
文献类型：
--
作者：
Davern, Timothy J.;Chalasani, Naga
严重药物性肝损伤是一个相对罕见但重要的公共卫生问题。从临床治疗试验中推断该问题的发生率受到许多问题的混淆，包括临床试验规模相对较小，参与研究的排除标准以及对肝损伤的积极监测。了解药物性肝损伤的发病机制及其预防和治疗的进展可能需要在上市后的“真实世界”环境中识别和仔细描述严重病例，作为协调一致的多中心精心策划的努力的一部分。药物性肝损伤网络（DILIN）就是这种努力的一个例子。
Severe drug-induced liver injury is a relatively rare but important public health problem. Extrapolating the incidence of this problem from clinical treatment trials is confounded by a number of issues, including the relatively small size of clinical trials, exclusion criteria for study participation, and active surveillance for liver injury. Advances in understanding the pathogenesis of drug-induced liver injury, as well as its prevention and treatment, will likely require the identification and careful characterization of severe cases in the post-marketing, "real-world" setting as part of a concerted, multi-center, well-orchestrated effort. The Drug-Induced Liver Injury Network (DILIN) represents one example of such an effort.